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Abstract: Background: Our objective was to investigate trends over time in longevity and reasons for replacement with or without extraction of pacemaker leads after first implantation. Methods: Data collected between 1984 and 2006 in the national Dutch pacemaker registry were used. This registry covered 84% of sold leads. First lead replacement with or without extraction of one or more leads implanted with a first pacemaker generator was the endpoint of interest. The time interval of and reason for first replacement were analyzed. A 7‐year follow‐up interval after first implantation was used to analyze changes over time. Results: During 22 years of data collection, 138,225 leads were implanted with a first pacemaker generator. Within a mean 5.5 (SD 4.4) years for 7,377 patients one or more leads were extracted for the first time. In total, 8,849 leads (6.4%) were replaced or extracted. The main reasons for first replacement of leads with or without extraction were insulation failures (14.6%), infection (8.8%), displacement (7.6%), or for elective reasons (10.0%). The number of insulation failures peaked during 1991–1995. Conclusions: Despite improvements in pacing techniques and experience with cardiac devices, we found that insulation and conductor failures, and complications such as infections, did not diminish over the 20 years of the registry. Continuing attention in clinical practice for the evaluation of these adverse outcomes and maintaining quality registries is warranted, whereas manufacturers should use this information to further improve their devices. [ABSTRACT FROM AUTHOR]

The implantation of cardiac pacemakers has become a well-established therapy for conduction disorders and sinus node dysfunction. In many countries pacemaker registries have been initiated in order to collect information on patient characteristics, trends in numbers and the types of pacemakers used, to identify problematic devices, and for safety monitoring. For this utilisation study the Central Pacemaker Patients Registration (CPPR) from the Netherlands Pacemaker Registry Foundation (CPPR-SPRN) containing data collected for more than 20 years was used. During this period nearly 97,000 first pacemakers were implanted. Analyses show an increase in the rate of implanted devices. The change in pacemaker type from VVI to DDD, followed by biventricular stimulation, is reflected by the number of simultaneously implanted leads, which is partly a consequence of cardiac resynchronisation therapy. Our data demonstrate that indications for implantation and type of pacemaker are comparable with other European countries., Competing Interests: Conflict of interestBoth L.M. de Vries and B.H.C. Stricker also work for the Dutch Health Care Inspectorate, a governmental supervisory organisation for healthcare. The work described in this paper was explicitly not performed on behalf of the inspectorate. M.J.G. Leening reports receiving grants and fees from the European Society of Cardiology (ESC), Netherlands Society of Epidemiology (VvE), American Heart Association (AHA), Prins Bernhard Cultuurfonds, Erasmus University Trustfonds, and Stichting De Drie Lichten, all unrelated to the content of this paper.

After the implantation of the first pacemakers in the Netherlands, controlling the quality of the implantation procedure and the device became an important issue for cardiologists, technicians and manufacturers. Over the years, the cooperation between the different workers in this field led to the development of new devices and novel features in the pacemakers, ensuring improvement in the quality of life of the pacemaker patient. This article gives an impression of how registration in national and local novel systems contributed to this development. (Neth Heart J 2008;16(Suppl1):S9-S11.).